Women's Heart Attack Research Program: Stress Ancillary Study

Launched by NYU LANGONE HEALTH · Sep 22, 2016

Keywords

ClinConnect Summary

The Women's Heart Attack Research Program: Stress Ancillary Study is looking at how stress affects women who have experienced a heart attack, also known as a myocardial infarction (MI). In this study, women who have shown signs of a heart attack, such as chest pain and abnormal heart test results, will answer questions about their stress levels two months after their heart attack. If their stress levels are high, they may be invited to join the study, where they will be randomly assigned to either receive standard care or participate in an 8-week stress management program. The researchers will follow up with participants for six months to see how they are doing.

To be eligible for this study, women need to be at least 21 years old and have experienced symptoms of a heart attack, along with specific test results confirming it. They must also be willing to participate and complete all study requirements. However, women with certain conditions, like severe depression or significant cognitive impairment, won't be able to join. This study aims to better understand how managing stress can help women recover after a heart attack.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Acute ischemic symptoms compatible with diagnosis of MI, such as chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms
• * Objective evidence of MI (either or both of the following):
• • Elevation of troponin to above the laboratory upper limit of normal
• • ST segment elevation of ≥1mm on 2 contiguous ECG leads
• • Willing to provide informed consent and comply with all aspects of the protocol
• • Age ≥ 21 years
• • Female sex
• • PSS-4 score ≥6 at 2 month follow up visit after MI
• Exclusion Criteria:
• • Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma.
• • Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15)
• • Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening)
• • History of or current diagnosis of psychosis (EHR review)
• • Significant cognitive impairment (EHR review or evident during screening)
• • Current participation in another behavioral clinical trial.